Grant Number:	1R01CA292236-01 Interpret this number
Primary Investigator:	May, Folasade
Organization:	University Of California Los Angeles
Project Title:	Evaluating a Multilevel Intervention to Increase Colonoscopic Follow-Up After Abnormal Stool-Based Colorectal Cancer Screening in a Community Safety-Net Setting
Fiscal Year:	2024

Project Summary/Abstract Colorectal cancer (CRC) is the second most common cause of cancer-related mortality in the United States (U.S.). Although several effective prevention and early detection screening methods are available, screening remains underutilized. The most feasible CRC screening modality for average-risk individuals in low resource settings, such as Federally Qualified Health Centers (FQHCs), is the stool-based fecal immunochemical test (FIT). One challenge of using FIT, however, is that follow-up colonoscopy is required after an abnormal (i.e., positive) result to check the colon and rectum for polyps or cancer. The benefit of FIT screening on CRC risk and mortality is realized only if timely colonoscopy is achieved. FQHCs are an integral component of the safety-net health system and represent a strong infrastructure for health service delivery research. Prior research suggests that only 18-57% of FQHC patients with abnormal stool-based screening results receive colonoscopy. There is limited research that focuses on identifying effective strategies to improve follow-up after an abnormal FIT result. In addition, much of the prior research has been conducted in integrated healthcare settings, although most care for underserved populations is delivered through a patchwork of public and private primary care providers, specialty providers and hospital settings. Therefore, it is paramount to understand how to increase follow-up of abnormal FIT results in these complex and real-world settings, which can yield findings with more relevance for the most vulnerable patient subgroups. In the proposed application, we will utilize a pragmatic, cluster randomized trial design within one of the largest FQHCs in the nation to test the effectiveness of a multilevel and multicomponent intervention (patient, provider, health system) that targets several barriers to follow-up in both the FQHC (primary care) and GI specialty care settings. The intervention is informed by prior research and is innovative in that it addresses barriers to follow-up colonoscopy in non-integrated primary care settings and within GI specialty care settings and strengthens care coordination between FQHCs and GI providers. The study will be conducted in 6 clinics within the same FQHC system. Three sites will be randomized to usual care and three to the intervention condition. The specific aims are to: 1) compare the effectiveness of the multilevel intervention to the usual care condition on receipt of a colonoscopy within 6 months of an abnormal FIT result (primary outcome); 2) systematically assess the quality of and challenges to intervention implementation to understand the feasibility and relative importance of intervention elements; and 3) measure the cost of intervention implementation to inform potential for dissemination and spread. The proposed study addresses important gaps in CRC prevention and control research by focusing on completion of the CRC screening process in a medically underserved population. Findings have the potential to change clinical practice and can be adapted for other FQHCs and clinical settings that face similar challenges in managing patients with abnormal FIT results.





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